Latest database descriptions

A cohort study of patients with advanced, unresectable (stage IIIB) metastatic (stage IV) non-squamous non-small cell lung cancer (NSCLC) or in relapse starting treatment with Avastin® in combination with chemotherapy as first line treatment of metast...

February 04 2022

This observational study will evaluate modality, efficacy and safety of Avastin (bevacizumab) as first-line treatment in combination with chemotherapy in patients with inoperable advanced, metastatic or recurrent non-squamous non-small cell lung cancer in clinical practice
1. To describe characteristics of patients treated with Avastin®: demographic and clinical characteristics, history of the disease, and previous disorders and conditions,
2. To describe methods of use of Avastin® in follow-up: doses and durations of treatment with Avastin® (number of cycles); chemotherapy treatments used in combination with treatment with Avastin®; discontinuation of treatment with Avastin® (temporary and permanent) and reasons; treatment strategies set up after discontinuation of treatment with Avastin®,
3. To describe overall survival of patients treated with Avastin®,
4. To describe the safety profile of treatment with Avastin®: serious and non-serious adverse events and targeted adverse events,
5. To describe quality of life: Spitzer's quality of life questionnaire,
6. To describe therapeutic management of patients with non-squamous cell NSCLC in first-line chemotherapy of metastatic disease not receiving Avastin®: compilation of an anonymous registry over a 3-month period starting with time of scientific set up by the investigator.

Case-Control Study Based on Childhood Cancer Geolocalisation

January 19 2022

To study the influence of several environmental exposures on the risk of childhood cancer - proximity to power lines and exposure to electric and magnetic fields at extremely low frequency - proximity to traffic lanes and environmental exposure to benzene and other pollutants - exposure to living spaces with natural ionising radiation, especially radon and gamma radiation - proximity to industrial sites

Identification of factors allowing a therapeutic anemia management optimization in CKD patients treated with C.E.R.A.

November 26 2021

Primary Objective: To identify the potential factors of optimizing the therapeutic management of renal anemia with C.E.R.A.
Secondary Objectives:
- Analysis of the therapeutic response to C.E.R.A., according to 4 definitions (reach or maintenance of the Hb concentration within the therapeutic target range of [10-12] g/dL, limitation of Hb variability at +/- 1 g/dL from the baseline value, both above criteria, or at least one of the above criteria, after a 3-month treatment period)
- Description of patient and disease characteristics at first C.E.R.A. injection
- Description of the evolution of CKD management (physical examination, laboratory parameters including Hb values and renal function, prior and ongoing concomitant treatments for anemia, as well as concomitant diseases and treatments) under C.E.R.A. treatment
- Search for any associations/correlations between variables and detection of particular profiles.

Prospective pharmaco-epidemiological study aiming to describe the management of relapsed or refractory chronic lymphocytic leukemia (CLL) patients retreated with MabThera®

November 26 2021

Primary Objective: To describe the chemotherapy regimens combined with MabThera® in relapsed or refractory CLL patients having previously received a first or second-line
treatment containing MabThera®
Secondary Objectives:
- Describe efficacy of treatment: overall response (OR), complete response (CR), partial response (PR), progression-free survival (PFS), time to next treatment (TTNT), overall survival (OS) in the total cohort and in the following subgroups: refractory (Yes/No), age (< or >= 70 years), 17p deletion (Yes/No), 11q deletion (Yes/No).
- Describe the choice of chemotherapy regimen in patient subgroups defined as: refractory (Yes/No), age (< or >= 70 years), 17p deletion (Yes/No), 11q deletion (Yes/No)
- Describe MabThera® treatment regimens (dose, number of cycles),
- Describe safety of treatment: all adverse events occurring during the study,
- Describe hospitalizations related to an adverse event throughout the study period.
Exploratory Objectives:
-Analysis of maximal response duration at last line before inclusion will be performed quantitatively and by classes, overall and by age, in all patients and according to number of previous lines of treatment.
- Primary criterion will be also described according to the following subgroups:
- last previous treatment before current relapse included the same/not the same chemotherapy treatment as first induction treatment
- report of Normalized creatinine clearance result < 60 (ml/min/1.73 m²) at baseline (yes/no) (renal insufficiency).
- In patients with HBs antigen positive or anti-HBc antibody positive, analysis of HBV prophylaxis and HBV treatment will be performed by visit
- Multinomial regression on choice of chemotherapy given at first cycle
- Logistic model on response

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